Bioequivalence study of Xaliquis 5 (5 mg Apixaban) film-coated tablet produced by PT Imedco Djaja in comparison with Eliquis (5 mg Apixaban) film coated tablet manufactured by Bristol-Myers Squibb Company, packaged and released by Catalent Anagni S.r.l, imported by PT Pfizer Indonesia.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-G0W0QCA
Tanggal Input Registry : 12-10-2023

16-05-2023
AUCt and Cmax
AUCinf, tmax, half-life
 
Bioequivalence study of Xaliquis 5 (5 mg Apixaban) film-coated tablet produced by PT Imedco Djaja in comparison with Eliquis (5 mg Apixaban) film coated tablet manufactured by Bristol-Myers Squibb Company, packaged and released by Catalent Anagni S.r.l, imported by PT Pfizer Indonesia.
Bioequivalence study of Xaliquis 5 (5 mg Apixaban) film-coated tablet produced by PT Imedco Djaja in comparison with Eliquis (5 mg Apixaban) film coated tablet manufactured by Bristol-Myers Squibb Company, packaged and released by Catalent Anagni S.r.l, imported by PT Pfizer Indonesia.
Interventional
The reference drug was Eliquis® (5 mg Apixaban) film coated tablet manufactured by Bristol-Myers Squibb Company, packaged and released by Catalent Anagni S.r.l, imported by PT Pfizer Indonesia. The test drug was Xaliquis 5 (5 mg Apixaban) film coated tablet produced by PT Imedco Djaja. In the morning of the sampling as scheduled, subjects were given one dose of Apixaban products of either formulation (reference or test), as per randomization scheme with 240 mL of water in sitting position.
18
 

Inclusion Criteria:

Willing to sign the informed consent, Age 18 – 55 years, Body mass index between 18 – 25 kg/m2, Normotensive (systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 60-80 mmHg), heart rate 60 – 90 beats per minute,

Exclusion Criteria:

Contraindicated and/or has history of hypersensitivity to Apixaban or related drug, With history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease, Using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the dosing day, Participated in any clinical study within 3 months prior the study, Donated or lost 300 mL (or more) of blood within 3 months prior the study, Smoke more than 9 sticks of cigarettes a day, Have any bleeding or coagulation disorder, with history of alcohol and drug abuse, Non-healthy male (non-healthy criteria is determined by abnormal values or if outside the normal range of value and clinically significant effects based on doctors justification on the result of laboratory test include routine hematology, liver function, renal function, blood sugar and urinalysis, history of disease, and physical examination), show abnormal limit or not within the acceptance range (clinically significant effect based on doctor’s justification) in the electrocardiography (ECG) test result, show abnormal result in the prothrombin time (PT) and activated partial thromboplastin time (aPTT), Indicate the positive result on test for HbsAg, Anti-HCV and anti-HIV, With the history of alcohol and drug abuse If the study is conducted in Covid-19 pandemic situation, the exclusions criteria below must be applied: a. With history of direct contact with a Covid-19 positive person within last 14 days, b. With history or present sore throat, fever (temperature more than 37oC) or short of breath within last 14 days, c. Positive to Covid-19 antigen rapid test.
 
KET-282/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
apt. Noviyanto, S.Farm